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Two-Tier OTC Monograph Approach Could Come With User Fee Revamp

Executive Summary

One tier could provide two-year exclusivity, should FDA request clinical trials for new conditions or ingredients, under a US Senate discussion draft. Essentially stalled monograph process would be replaced by deadlines for FDA action in under two years.

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Shorter Exclusivity In House OTC Monograph Bill Could Gain Industry Acceptance To Speed Passage

The length of exclusivity periods is the only major difference between pending US House and Senate bills, both largely based on a proposal developed by FDA and drug industry representatives. Committees in both chambers are expected to vote on moving the bipartisan proposals to floor votes within two months.

Shorter Exclusivity In House OTC Monograph Bill Could Gain Industry Acceptance To Speed Passage

The length of exclusivity periods is the only major difference between pending US House and Senate bills, both largely based on a proposal developed by FDA and drug industry representatives. Committees in both chambers are expected to vote on moving the bipartisan proposals to floor votes within two months.

OTC Monograph Reform Momentum Carries Potential Exclusivity Snag

Support was unanimous during House Health Subcommittee markup for draft legislation on streamlining FDA's monograph system by eliminating public rulemakings from the process and allowing the agency to make decisions with administrative orders. Two-year exclusivity for some products didn't go over so well.

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